Shared Decision Making in Older Adults With Distal Radius Fractures

NCT ID: NCT02782299

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-11-30

Brief Summary

This is a study to investigate the use of a Decision Aid for shared decision making in older adults with distal radius fractures. The goal is to improve patient decisions making, and improve patient knowledge through the use of a validated decision aid.

Detailed Description

Shared decision making has become a increasingly important with the goal of helping patients make decisions that more align with patients values and goals. Decision aids are validated instruments that provide unbiased information and guide patients through questions that allow patients to clarify patients goals.

Older adults with distal radius fractures have increasing evidence of ability to tolerate residual deformity with little to no functional deficits, which has called into question the indications for surgery. In situations where the operative indications are not clear, it is important to engage the patient in the risk and benefits of the decision.

This trial is a prospective trial with two groups, one standard of care, and one with the decision aid.

Conditions

Radius Fracture

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

This group will not be exposed to the decision aid. Patients will complete the same surveys, and will be followed for the same length of time.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Decision Aid

This group will be exposed to the decision aid before the patients appointment with the surgeon. Patients will also complete the same outcome surveys, and will be followed for the same length of time.

Group Type: EXPERIMENTAL

Decision Aid

Intervention Type: OTHER

Decision aid which is still under revision will include unbiased information to assist is clarifying values and informing patients with distal radius fractures.

Interventions

Decision Aid

Decision aid which is still under revision will include unbiased information to assist is clarifying values and informing patients with distal radius fractures.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Distal radius fracture within the past 2 weeks
• Initial appointment seeing Attending
• Age 65+

Exclusion Criteria

• Non english speaker
• Dementia or other mental limitation preventing ability to complete survey
• Other traumatic injuries in extremity that would affect surgical decision

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Calfee, MD

Role: STUDY_DIRECTOR

Washington University School of Medicine

Locations

Washington University-St Louis

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201512001

Identifier Type: -

Identifier Source: org_study_id